In order to bring products to the market, it is mandatory for medical device manufacturers to have a Quality Management System (QMS) in place. We can assist you to achieve this end with the following services:

  • Establishment and implementation of Quality Management Systems (QMS).
  • Preparation for certification of Quality Management Systems (QMS) according to FDA QSR, EU Directives (AIMD, MDD, and IVD) and Regulations (MDR and IVDR), EN/ISO13485 and MDSAP,
  • Liaison with Certification Bodies.
  • Pre-certification audits prior to FDA audits, Notified Body Audits or other bodies.
  • Periodic compliance First and Second party Audits including Mock Audits.
  • Maintenance of Quality Management Systems (QMS) and acting as your Quality Assurance Manager.